AzTrials
AzTrials

Atrial FibrillationEUROSAFNCT02973984

The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF)

An observational study of Atrial Fibrillation, run by Alberto Pilotto at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Preliminary data suggest that: 1. a different risk of mortality, as assessed by the Multidimensional Prognostic Indices (MPI), may influence the anticoagulant prescription in older subjects with Atrial Fibrillation (AF); 2. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Atrial Fibrillation
How many people
3,000 participants
Where
1 siteItaly
Study dates
18 Nov 2016to Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: This is a cross-national, prospective, observational study that will include about 3.000 older subjects (aged ≥ 65 years) with AF hospitalized in 30 European geriatric centers (about 100 subjects/center) for an acute disease or a relapse of a chronic diseases. The study is in the frame of the Special Interest Group on CGA (Comprehensive Geriatric Assessment) of the EUGMS (European Union Geriatric Medicine Society).

Who may be able to join

  • This is an observational study in which all consecutive patients admitted to the Geriatrics Units involved in the project will be screened for inclusion. The inclusion criteria are:
  • patients of both genders, aged 65 years and older
  • admitted to hospital for acute diseases or a relapse of chronic diseases
  • with a documented diagnosis of non valvular AF
  • who are willing to participate in the survey and give their informed consent

Who cannot join

  • age less than 65 years
  • patients who have not provided informed consent

Trial locations and contacts

1 site in 1 country.

Alberto Pilotto, MD contact

0039 010 563 ext. 4467

alberto.pilotto@galliera.it

Alessandra Argusti, PDH contact

0039 010 563 ext. 4188

a.argusti@galliera.it

Italy1 site, 1 recruiting

  • S.C. Geriatria

    Genova, 16128

    Alberto Pilotto, MD, 0039 010 536 ext. 4467, alberto.pilotto@galliera.it

    Recruiting

Other trials in Italy

About this study

Official title: Evaluating the Efficacy and Risks of Anticoagulant Treatments in Multimorbid Frail Older Subjects With Atrial Fibrillation. The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF)

Preliminary data suggest that:

  1. a different risk of mortality, as assessed by the Multidimensional Prognostic Indices (MPI), may influence the anticoagulant prescription in older subjects with Atrial Fibrillation (AF);
  2. the presence of multidimensional impairment, disability and multi-morbidities are usually not included in the decision algorithm of the more appropriate treatments in older patients with AF;
  3. considering the prognostic information, as calculated by the MPI, can be useful to physicians in identifying older patients with AF that can benefit from anticoagulant treatment in term of increased survival.
Read the detailed description

The main objective of this observational study is to evaluate in a "real world" population of older hospitalized patients with AF, the clinical benefit/risk ratio of the anticoagulant treatments in terms of:

  1. mortality (all-cause and vascular mortality);
  2. thromboembolic events, i.e. stroke, systemic embolism;
  3. bleeding side-effects, especially intracranial and gastrointestinal bleeding Secondary objective of the study is to evaluate whether a different prognostic profile, as determined by the MPI, is associated with 1) different kind of treatments for AF (no treatment vs anticoagulants, i.e. Vitamin K Antagonists (VKA) or novel oral anticoagulant (NOACs); and 2) differences in the main outcomes (i.e. mortality, major thromboembolic events and side effects including bleeding events).
Keywords
Anticoagulant Treatments, Multidimensional Prognostic Index (MPI), Comprehensive Geriatric Assessment (CGA), Frailty, Elderly, Atrial Fibrillation
Medical subject headings
Atrial Fibrillation, Frailty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. all-cause mortality and vascular mortality

    Vascular mortality is defined as: stroke, embolism, myocardial infarction

    Measured: 12 months

  2. thromboembolic events,

    stroke and/or systemic embolism

    Measured: 12 months

  3. bleeding side-effects

    major intracranial and gastrointestinal bleeding.

    Measured: 12 months

Secondary outcomes (4)

  1. vascular-related hospitalization rates

    stroke and/or systemic embolism

    Measured: 12 months

  2. bleeding-related hospitalization rates

    intracranial and gastrointestinal bleeding

    Measured: 12 months

  3. MPI value and different mortality risk class

    mild, moderate, severe

    Measured: 12 months

  4. presence/absence of anticoagulant treatments

    presence of anticoagulant treatments

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2016 (estimated)
  2. Study start18 Nov 2016
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02973984
Sponsor's protocol ID
28UCS2015
Other IDs
162REG2016
Acronym
EUROSAF
Status last verified
Sep 2023
First submitted
24 Oct 2016
Last updated
7 Sep 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Wann LS, Curtis AB, Ellenbogen KA, Estes NA 3rd, Ezekowitz MD, Jackman WM, January CT, Lowe JE, Page RL, Slotwiner DJ, Stevenson WG, Tracy CM, Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Le Heuzey JY, Kay GN, Olsson SB, Prystowsky EN, Tamargo JL, Wann S. Management of patients with atrial fibrillation (compilation of 2006 ACCF/AHA/ESC and 2011 ACCF/AHA/HRS recommendations): a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 May 7;61(18):1935-44. doi: 10.1016/j.jacc.2013.02.001. Epub 2013 Apr 1. No abstract available.

    PubMed 23558044

  • Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH; ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12(10):1360-420. doi: 10.1093/europace/euq350. No abstract available.

    PubMed 20876603

  • Hylek EM, D'Antonio J, Evans-Molina C, Shea C, Henault LE, Regan S. Translating the results of randomized trials into clinical practice: the challenge of warfarin candidacy among hospitalized elderly patients with atrial fibrillation. Stroke. 2006 Apr;37(4):1075-80. doi: 10.1161/01.STR.0000209239.71702.ce. Epub 2006 Mar 9.

    PubMed 16527999

  • Pugh D, Pugh J, Mead GE. Attitudes of physicians regarding anticoagulation for atrial fibrillation: a systematic review. Age Ageing. 2011 Nov;40(6):675-83. doi: 10.1093/ageing/afr097. Epub 2011 Aug 5.

    PubMed 21821732

  • Maes F, Dalleur O, Henrard S, Wouters D, Scavee C, Spinewine A, Boland B. Risk scores and geriatric profile: can they really help us in anticoagulation decision making among older patients suffering from atrial fibrillation? Clin Interv Aging. 2014 Jul 15;9:1091-9. doi: 10.2147/CIA.S62597. eCollection 2014.

    PubMed 25053883

  • Sinnaeve PR, Brueckmann M, Clemens A, Oldgren J, Eikelboom J, Healey JS. Stroke prevention in elderly patients with atrial fibrillation: challenges for anticoagulation. J Intern Med. 2012 Jan;271(1):15-24. doi: 10.1111/j.1365-2796.2011.02464.x. Epub 2011 Oct 31.

    PubMed 21995885

  • Zarraga IG, Kron J. Oral anticoagulation in elderly adults with atrial fibrillation: integrating new options with old concepts. J Am Geriatr Soc. 2013 Jan;61(1):143-50. doi: 10.1111/jgs.12042. Epub 2012 Dec 18.

    PubMed 23252345

  • Barco S, Cheung YW, Eikelboom JW, Coppens M. New oral anticoagulants in elderly patients. Best Pract Res Clin Haematol. 2013 Jun;26(2):215-24. doi: 10.1016/j.beha.2013.07.011. Epub 2013 Jul 21.

    PubMed 23953909

  • Sardar P, Chatterjee S, Chaudhari S, Lip GY. New oral anticoagulants in elderly adults: evidence from a meta-analysis of randomized trials. J Am Geriatr Soc. 2014 May;62(5):857-64. doi: 10.1111/jgs.12799. Epub 2014 May 1.

    PubMed 24786913

  • Stollberger C, Finsterer J. Concerns about the use of new oral anticoagulants for stroke prevention in elderly patients with atrial fibrillation. Drugs Aging. 2013 Dec;30(12):949-58. doi: 10.1007/s40266-013-0119-3.

    PubMed 24170233

  • Crome P, Lally F, Cherubini A, Oristrell J, Beswick AD, Clarfield AM, Hertogh C, Lesauskaite V, Prada GI, Szczerbinska K, Topinkova E, Sinclair-Cohen J, Edbrooke D, Mills G. Exclusion of older people from clinical trials: professional views from nine European countries participating in the PREDICT study. Drugs Aging. 2011 Aug 1;28(8):667-77. doi: 10.2165/11591990-000000000-00000.

    PubMed 21812501

  • Gill TM. The central role of prognosis in clinical decision making. JAMA. 2012 Jan 11;307(2):199-200. doi: 10.1001/jama.2011.1992. No abstract available.

    PubMed 22235093

  • Pilotto A, Ferrucci L, Franceschi M, D'Ambrosio LP, Scarcelli C, Cascavilla L, Paris F, Placentino G, Seripa D, Dallapiccola B, Leandro G. Development and validation of a multidimensional prognostic index for one-year mortality from comprehensive geriatric assessment in hospitalized older patients. Rejuvenation Res. 2008 Feb;11(1):151-61. doi: 10.1089/rej.2007.0569.

    PubMed 18173367

  • Pilotto A, Gallina P, Fontana A, Sancarlo D, Bazzano S, Copetti M, Maggi S, Paroni G, Marcato F, Pellegrini F, Donato D, Ferrucci L. Development and validation of a Multidimensional Prognostic Index for mortality based on a standardized Multidimensional Assessment Schedule (MPI-SVaMA) in community-dwelling older subjects. J Am Med Dir Assoc. 2013 Apr;14(4):287-92. doi: 10.1016/j.jamda.2013.01.005. Epub 2013 Feb 9.

    PubMed 23402948

  • Siontis GC, Tzoulaki I, Ioannidis JP. Predicting death: an empirical evaluation of predictive tools for mortality. Arch Intern Med. 2011 Oct 24;171(19):1721-6. doi: 10.1001/archinternmed.2011.334. Epub 2011 Jul 25.

    PubMed 21788535

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Alberto Pilotto at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alberto Pilotto, MD (0039 010 563 ext. 4467, alberto.pilotto@galliera.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

all-cause mortality and vascular mortality (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02973984, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in